11/16/2015
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`ISTA Plamaceu ic:-is Receives FDA Apmm-I fa Brande;
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`% Drugs.com
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`Know more. Besune.
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`FDA Approves Bromday
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`ISTA Pharmaceuticals Receives FDA Approval for Bromday
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`IRVINE, Calif., Oct. 16 /PRNewswire-FirstCal|/ -- ISTA Pharmaceuticals, Inc. today announced the U.S.
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`Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application L7.‘
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`(sN DA) for Bromday (bromfenac ophthalmic solution) 0.09% as a once-daily prescription eye drop for the
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`treatment 3 of postoperative inflammation and reduction of ocular pain in patients who have undergone
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`cataract extraction. ISTA expects to launch Bromday (formerly referred to as XiDay) prior to the end of 2010.
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`"Bromday is the only once-daily ophthalmic nonsteroidal anti-inflammatory drug (N SAID) for the treatment of
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`postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.
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`We believe the convenience of a once-daily eye drop will help with treatment compliance and benefit patients
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`recovering from cataract surgery," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of
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`ISTA. "Bromday is an important addition to our growing prescription eye and allergy product p_Q|1[Q|ig :71‘.
`Within just a few weeks, our expanded sales force will be ready to promote Bromday to U.S.-based
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`ophthalmologists, along with Bepreve, our recently launched eye drop for the treatment of itching associated
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`with allergic conjunctivitis.
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`"Since the Bromday approval process required additional clinical investigations beyond those conducted for
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`the original approval of Xibrom 0.09%, we are seeking a three-year exclusivity period under the Drug Price
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`Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act. Bromday
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`represents a significant step in extending our successful bromfenac-based product line established when we
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`launched Xibrom, our twice-daily NSAID for use following cataract surgery, in 2005. In addition, we are
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`evaluating a new formulation and lower concentrations of bromfenac called Remura for the potential
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`treatment of dry eye which is now in Phase 3 clinical studies. Beginning in mid-November, we will begin
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`detailing Bromday to ophthalmologists; we expect to discontinue the twice-daily Xibrom product in early
`201 1
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`About Bromday
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`Bromday is a once-daily eye drop formulation of a nonsteroidal anti-inflammatory compound for the treatment
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`of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract
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`extraction. Bromday is approved for dosing once-daily beginning one day prior to surgery, on the day of
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`surgery and continuing for the first 14 days after surgery. Since 2005, ISTA has marketed Xibrom
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`(bromfenac ophthalmic solution) 0.09% in the U.S. for twice—daily use for the treatment of postoperative
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`inflammation and the reduction of ocular pain in patients who have undergone cataract surgery. ISTA
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`acquired U.S. ophthalmic rights to bromfenac in May 2002 under a license from Senju Pharmaceuticals Co.
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`Ltd. Xibrom is the 2010 dollar market 3 share leader in the $335 million U.S. ophthalmic nonsteroidal anti-
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`inflammatory market. ISTA reported Xibrom net sales of $81.1 million for the year ended December 31,
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`2009, and net sales of $41.4 million in the first six months of 2010, up 22% over the first six months of 2009.
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`Indications and Usage
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`PAGE 1 OF 3
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`SENJU EXHIBIT iiss
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`LUPIN V SENJU
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`IPR2015—01105
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`11I16I2015
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`ISTA Ph:-rmaceu ids Receives FDA Approve! fa Branch;
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`Bromday is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative
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`inflammation and reduction of ocular pain in patients who have undergone cataract extraction.
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`Dosage and Administration
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`Instill one drop into the affected eye(s) once-daily beginning 1 day prior to surgery, continued on the day of
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`surgery and through the first 14 days post-surgery.
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`Dosage Forms and Strengths
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`Topical ophthalmic solution: bromfenac 0.09%
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`Contraindications
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`None
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`Warnings and Preutions
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`- Sulfite Allergic Reactions
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`- Slow or Delayed Healing
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`- Potential for cross-sensitivity
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`-
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`Increased bleeding of ocular tissues
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`- Corneal effects including keratitis
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`- Contact Lens Wear
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`Adverse Reactions
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`The most commonly reported adverse reactions in 2-7% of patients were abnormal sensation in the eye,
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`conjunctiva] hyperemia and eye irritation (including burning/stinging).
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`Full prescribing information will be available soon on ISTA Pharmaceuticals‘ website at
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`http:IIwww.istavision.com.
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`About ISTA Pharmaceuticals
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`ISTA Pharmaceuticals, Inc. is the fourth largest and fastest growing branded prescription eye care business
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`in the United States, with an expanding focus on allergy therapeutics. ISTA currently markets five products,
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`including treatments for ocular inflammation and pain associated with cataract surgery, glaucoma, and ocular
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`itching associated with allergic conjunctivitis. The Company's development pipeline contains additional
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`candidates in various stages of development to treat dry eye, ocular inflammation and pain, and nasal
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`allergies. Headquartered in Irvine, California, the Company generated 2009 revenues of $111 million. For
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`additional information about ISTA Phannaceuticals, please visit the corporate website at
`www.istavision.com.
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`11I16l2015
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`ISTA Ph:-rmaoeu iws Receives FDA Approv:-I fa Branch;
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`FOR WA RD-L OOKING S TA TEMEN TS
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`Any statements contained in this press release that refer to future events or other non-historical matters are
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`forward-looking statements. Without limiting the foregoing, but by way of example, statements contained in
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`this press release related to the expected launch of Bromday in 2010, IS TA 's anticipated devotion of
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`resources toward the marketing of Bromday and BEPREVE, IS TA 's intention to discontinue marketing and
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`selling Xibrom in 201 1, the potential exclusivity for Bromday under the Drug Price Competition and Patent
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`Term Restoration Act, and the completion of Phase 3 studies for REMURA (bromfenac ophthalmic solution
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`for dry eye), are fonrvard-looking statements. Except as required by law, IS TA disclaims any intent or
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`obligation to update any fonrvard-looking statements. These forward-looking statements are based on IS TA 's
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`expectations as of the date of this press release and are subject to risks and uncertainties that could cause
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`actual results to differ maten'ally. Important factors that could cause actual results to differ from current
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`expectations include, among others, delays and uncertainties related to the FDA or other regulatory agency
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`approval or actions and such other risks and uncertainties as detailed from time to time in IS TA 's public filings
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`with the U. S. Securities and Exchange Commission, including but not limited to IS TA '5 Annual Report on
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`Form 10-K for the year ended December 31, 2009, and its Quarterly Report on Forms 10—Q for the quarters
`ended March 31 and June 30, 2010.
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`SOURCE ISTA Pharmaceuticals, Inc.
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`CONTACT: Investor Relations: Lauren Silvernail, +1-949-788-5302, |silvernail@istavision.oom, or Jeanie
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`Herbert, +1-949-789-3159, jherbert@istavision.com; or Juliane Snowden, Burns McClellan, +1-212-213-
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`0006, jsnowden@burnsmc.com; General Media: Justin Jackson, Burns McClellan, +1-212-213-0006,
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`iiackson@burnsmc.com; Trade Media: Tad Heitmann, BioComm Network, +1-949-494-3140,
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`theitmann@BioCommNetwork.com
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`Web Site: http:IIwww.istavision.com
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`Posted: October 2010
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`Related Articles:
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`-
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`-
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`ISTA Pharmaceuticals Receives Action Date for FDA Review of Once-Daily XiDay - March 9, 2010
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`ISTA Pharmaceuticals Submits Supplemental New Drug Application to the FDA for Once-Daily
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`XiDay - December 23, 2009
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`Bromday (bromfenac) FDA Approval History
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`View comments >
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